HIV Exposure In Utero and Metabolic Disease Risk in HIV-Negative Young Adults

Completed

• Conditions: HIV-exposed Uninfected
• Interventions: Other: In Utero HIV Exposure; Other: No In Utero HIV Exposure

• Registration Number: NCT04132830
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-21
• Primary Completion: 2024-07-26
• Study Completion: 2024-07-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-Exposed Uninfected Dyads	In Utero HIV Exposure	Mothers who had HIV during pregnancy and their HIV-negative young adult offspring
HIV-Unexposed Uninfected Dyads	No In Utero HIV Exposure	Mothers and young adults without HIV

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI)	Baseline
Activated CD8+ T cells	Baseline	Flow cytometry

Secondary Outcome Measures

Name	Time	Method
Immune cell subsets	Baseline	Flow cytometry
Frequency of Asthma	Baseline, Ever
DNA methylation patterns	Baseline	Epigenome-wide analysis
Glucose tolerance	Baseline	Oral glucose tolerance test
Lipids	Baseline	Standard lipid panel (including HDL, triglycerides)
Blood pressure	Baseline	Systolic and diastolic
Hepatic fibrosis	Baseline	Transient elastography
Inflammatory markers	Baseline	ELISA
Abdominal fat mass	Baseline	Dual-energy x-ray absorptiometry
Hepatic fat content	Baseline	Transient elastography

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States